Summary: Develops, designs, documents and implements single-use systems for the biopharmaceutical industry; provides assistance and technical support to end-users necessary to ensure the successful implementation thereof.
- Ensures processes and products are compliant with cGMP and compatible with the regulatory environment required by our pharmaceutical customer base.
- Collaborates with other departments to ensure best practices are communicated throughout the organization.
- Supports the Quality department via creation of SOPs, availability during customer audits, deviation or excursion response, testing and analysis, etc.
- Supports continuous quality improvement initiatives throughout organization.
- Supports efficiency and lean manufacturing initiatives.
Single-Use System Specific:
- Develops single-use systems designs based on user and process requirements:
-Creates product specifications which meet customer design requirements while allowing for lean production and cost effective solutions.
-Analyzes product specifications and performance requirements to determine designs which can be produced via existing component portfolio, processing facilities and techniques.
-Prepares design layouts, assembly drawings, work orders, BOM's and other documents necessary for completion of projects.
-Provides resource allocation and cost estimates for production of single-use assembly designs.
- Manages library of single-use componentry for use in single-use assemblies:
-Evaluates single-use components to ensure fitness for purpose, e.g. sensor functionality, engagement testing, etc.
-Works with Quality, supply chain, and procurement to ensure consistent supply of single-use components.
- Supports single-use systems production:
-Ensures designs are manufactured accurate to developed specifications.
-Facilitates new biocontainer design implementation.
-Promotes efficient manufacturing techniques.
-Interfaces with and offers continuous improvement support for the MRP/ERP systems.
- Provides product support for single-use assemblies:
-Creates support documentation including process flow and recommended usage diagrams.
-Confers with customers and sales staff to discuss project status, provide technical support and otherwise facilitate implementation of product.
- Manages single-use systems projects to ensure that initiatives are met, timelines are adhered to, associated costs targets are achieved, etc.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
Bachelor's degree (B.S.) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Manufacturing Engineering, Industrial Engineering, Industrial Technology or equivalent technical discipline from four-year college or university.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
Other Skills and Abilities:
The ability to utilize basic computer skills is essential including the use of word-processing, spreadsheets and databases.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to clearly and effectively communicate, both verbally and in writing, with other departments at Meissner as well as parties external to the organization.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee frequently is required to walk and sit. The employee is occasionally required to stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
Occasional work may be done in an ISO Class 7 cleanroom environment. Powder free gloves, facemasks, hairnets, gowns and shoe covers must be worn. Because smokers continue to shed thousands of smoke particles even hours after smoking a cigarette and these particles will damage our products, only non-smokers are permitted to enter or work in the cleanroom.
Each employee of the Company is an at‑will employee, unless specifically notified otherwise in writing. This means that the terms and conditions of employment may be changed with or without cause. It also means an employee may terminate their employment at any time, for any reason, and the Company has the same right to terminate an employees’ employment at any time for any reason.
Meissner Filtration Products is Proud to be an Equal Opportunity Employer.